Ignite Creation Date:
2025-12-24 @ 4:13 PM
Ignite Modification Date:
2025-12-26 @ 8:41 AM
Study NCT ID:
NCT01912066
Status:
COMPLETED
Last Update Posted:
2014-09-30
First Post:
2013-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Multicenter, Double Blinded, Randomized, Parallel Assignment Study to Demonstrate the Efficacy of DA9601
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C116959', 'term': 'DA 9601'}, {'id': 'D016595', 'term': 'Misoprostol'}, {'id': 'D000894', 'term': 'Anti-Inflammatory Agents, Non-Steroidal'}, {'id': 'C056498', 'term': 'aceclofenac'}], 'ancestors': [{'id': 'D011459', 'term': 'Prostaglandins E, Synthetic'}, {'id': 'D011465', 'term': 'Prostaglandins, Synthetic'}, {'id': 'D011453', 'term': 'Prostaglandins'}, {'id': 'D015777', 'term': 'Eicosanoids'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D012898', 'term': 'Autacoids'}, {'id': 'D018836', 'term': 'Inflammation Mediators'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D018712', 'term': 'Analgesics, Non-Narcotic'}, {'id': 'D000700', 'term': 'Analgesics'}, {'id': 'D018689', 'term': 'Sensory System Agents'}, {'id': 'D018373', 'term': 'Peripheral Nervous System Agents'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D000893', 'term': 'Anti-Inflammatory Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D018501', 'term': 'Antirheumatic Agents'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 520}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'completionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-09-29', 'studyFirstSubmitDate': '2013-07-25', 'studyFirstSubmitQcDate': '2013-07-29', 'lastUpdatePostDateStruct': {'date': '2014-09-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-07-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the percentage of protected subjects (%)', 'timeFrame': '4 weeks', 'description': 'the definition of "protected" is the subjects with no erosions, in other words, either zero or 1 erosion found at stomach by the endoscopy.'}], 'secondaryOutcomes': [{'measure': 'A percentage of a protected subject (at duodenum), and of ulcer occurrence', 'timeFrame': '4 weeks', 'description': '1. The definition of "protected" is the subjects with no erosions, in other words, either zero or 1 erosion found at duodenum by the endoscopy.\n2. A percentage of ulcer occurrence'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['NSAID-associated Gastroduodenal Injury']}, 'descriptionModule': {'briefSummary': 'This is a phase IV clinical study to evaluate the preventive effectiveness of NSAID-Associated Gastroduodenal Injury. The study is consisted of multi-center, doubleblind, active-controlled, stratified randomized, parallel group. A tablet of DA9601, Cytotec (200ug of Misoprostol), Acrofen (100mg of Aceclofenac) will be assigned randomly to the subjects for four weeks.', 'detailedDescription': 'After filling an Informed consent form, subjects are joined the clinical trials. First of all, Screening test including the endoscopy test is performed.\n\nSubjects, which fit the inclusion/Exclusion criteria, are assigned randomly. Subjects takes investigation products as randomized.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Need to take NSAID pills for longer than four weeks\n* should be normal diagnosed by the endoscopy test\n\nExclusion Criteria:\n\n* The patients have gastric ulcer or duodenal ulcer within 30 days\n* The patients have a gastro-intestinal surgery within a year\n* The patients are taking the following drugs within seven days: H2 receptor antagonist, PPI, sucralfate, misoprostol, Stillen etc)'}, 'identificationModule': {'nctId': 'NCT01912066', 'briefTitle': 'A Multicenter, Double Blinded, Randomized, Parallel Assignment Study to Demonstrate the Efficacy of DA9601', 'organization': {'class': 'INDUSTRY', 'fullName': 'Dong-A ST Co., Ltd.'}, 'officialTitle': 'A Phase IV Clinical Trial to Evaluate the Preventive Effectiveness of NSAID-Associated Gastroduodenal Injury (Multi-center, Double-blind, Active-controlled, Stratified Randomized, Parallel Group)', 'orgStudyIdInfo': {'id': 'DA9601_PG_IV'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Stillen', 'description': 'Patients taking a tab of Stillen and a tab of placebo drug and a tab of NSAID', 'interventionNames': ['Drug: Stillen', 'Drug: NSAID (Aceclofenac)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cytotec', 'description': 'The subjects taking a tab of Cytotec, a tab of placebo drug, and a tab of NSAID', 'interventionNames': ['Drug: Cytotec (reference drug)', 'Drug: NSAID (Aceclofenac)']}], 'interventions': [{'name': 'Stillen', 'type': 'DRUG', 'armGroupLabels': ['Stillen']}, {'name': 'Cytotec (reference drug)', 'type': 'DRUG', 'armGroupLabels': ['Cytotec']}, {'name': 'NSAID (Aceclofenac)', 'type': 'DRUG', 'armGroupLabels': ['Cytotec', 'Stillen']}]}, 'contactsLocationsModule': {'locations': [{'zip': '614735', 'city': 'Busan', 'country': 'South Korea', 'facility': 'Inje University Busan Paik Hospital', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}], 'overallOfficials': [{'name': 'Sang-Yong Seol, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Inje University'}, {'name': 'Myoung-Gyu Choi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Catholic University of Korea'}, {'name': 'Oh Young Lee, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hanyang University'}, {'name': 'Dong Ho Lee, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Bundang Hospital'}, {'name': 'Yong Chan Lee, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Severance Hospital'}, {'name': 'Suck Chei Choi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wonkwang University School of Medicine & Hospital'}, {'name': 'Jong Sun Rew, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chonnam National University Hospital'}, {'name': 'Kang Moon Lee', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Saint Vincent's Hospital, Korea"}, {'name': 'Jae Young Jang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kyunghee University Medical Center'}, {'name': 'Hoon-jai Chun, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Korea University Anam Hospital'}, {'name': 'Sang-woo Lee, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Korea University Ansan Hospital'}, {'name': 'Moo In Park, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kosin University Gospel Hospital'}, {'name': 'Joong Goo Kwon, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Daegu Catholic University Medical Center'}, {'name': 'Geunam Song, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pusan National University Hospital'}, {'name': 'Seong Woo Jeon, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kyungpook National University Medical Center'}, {'name': 'Soo Taek Lee, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chonbuk National University Hospital'}, {'name': 'Jae Gyu Kim, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chung-Ang University Hosptial, Chung-Ang University College of Medicine'}, {'name': 'Poong-Lyul Rhee, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Samsung Medical Center'}, {'name': 'Kwang Jae Lee, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ajou University School of Medicine'}, {'name': 'Hyo Jin Park, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gangnam Severance Hospital'}, {'name': 'Byung Ik Jang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yeungnam University Hospital'}, {'name': 'Yong Woon Shin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Inha University Hospital'}, {'name': 'Dong Soo Han, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hanyang University'}, {'name': 'Sung Kook Kim, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kyungpook National University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dong-A ST Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}